An early preterm premature rupture of membranes (PPROM) occurs in about 3 to 17% of all pregnancies and leads to a premature birth within a few days in most cases. PPROM is therefore the cause of child morbidity and mortality in the early weeks of pregnancy, in particular before the completed 34th week of pregnancy. Ascending infections from the lower genital tract, which can lead to PPROM through the increase in the intraamnial pressure and the occurrence of shear forces, are one reason for the occurrence of a preterm premature rupture of the membranes.
Therapeutic measures for treating PPROM aim to restore and maintain the normal fluid volume in the amnion. To increase the amniotic fluid index (AFI), the volume of fluid of the amnion is continuously increased by means of an amnioinfusion (Tan L.-K et al., Test Amnioinfusion to Determine Suitability for Serail Therapeutic Amnioinfusion in Midtrimester Premature Rupture of Membranes, Fetal Diagn Ther (2003), 18: 183-189; Luigi A. et al., Transabdominal amnioinfusion in preterm premature rupture of membranes: a randomised controlled trial, BJOG: an International Journal of Obstetrics and Gynaecology (2005), Vol. 112, pp. 759-763; Tian-Lun Hsu et al., The Experience of Amnioinfusion for Oligohydramnios during the early second trimester, Taiwan J Obstet Gynacol (2007), Vol. 46 (4)).
The previously known methods for amnioinfusion for treating PROM are unsatisfactory, as the artificial amniotic fluid introduced from outside (physiological saline solution) very rapidly flows out of the uterus again, so the effect of the amnioinfusion is greatly reduced. The known methods related, for example, to a cervical occlusion with a fibrin gel (Zamlynski J, Bodzek P, Olejek A, Grettka K, Manka G., Results of amnioinfusion in pregnancies with oligohydramnios and non-ruptured fetal membranes, Med Wieku Rozwoj 2003; 7: 187-94) or the infusion of a fluid by means of a transcervical catheter (Machalski T, Sikora J, Bakon I, Magnucki J, Grzesiak-Kubica E, Szkodny E. Short-term and long-term fetal heart rate variability after amnioinfusion treatment of oligohydramnios complicated pregnancy, Ginekol Pol 2001; 72: 1107-11).
Catheters are used in the most varied areas of medicine. A balloon catheter is described in EP 1 557 193 B1, which is used to treat a congenital heart disease such as tricuspid atresia, pure pulmonary atresia or a complete reversal of large vessels. A balloon catheter is described in U.S. Pat. No. 5,226,889 A, which consists of a flexible shaft and at least one pair of inflatable balloons, the proximally situated balloon carrying a vessel support (stent). The vessel support is to be implanted into a patient by means of the balloon catheter. The above-mentioned catheters would not be suitable for use in an amnioinfusion. One problem is that the catheters cannot be fixed in the uterus wall. Furthermore, the problem of loss of fluid exists in amnioinfusion owing to the non-sealed puncture point in the uterus wall, so a continuous supply of fluid is necessary during the amnioinfusion. The danger of peritonitis is reduced or prevented by sealing using the balloon catheter system according to the invention.
A double balloon catheter for treating PPROM consists of a silicone tube with two separate balloons close to the cervical tip and a hole between these balloons, so an antiseptic solution, which is introduced from the outer end, can flow through the walls and branched channels into each balloon (Gramellini D, Fieni S, Kaihura C, Faiola S, Vadora E., Transabdominal antepartum amnioinfusion, Int J Gynaecol Obstet 2003; 83: 171-8). The described catheter is introduced via the cervix and the balloons are filled by infusion with PVP iodine solution through the branched channels. The balloons fix the catheter in the cervical channel, which is partly closed by operation clamps between the two balloons and is tightened after the filling thereof. The catheter described therein is to prevent the outflow of amniotic fluid via the cervix. However, when using this method there is a risk of an amnion infection syndrome (AIS) owing to infected amniotic fluid and extraneous bodies (catheters) in the cervix, as no continuous amnioinfusion takes place with fresh saline solution.